Rational Organisation of Adverse Drug Reaction Monitoring

The main pharmacoepidemiological method for assessing the efficacy and safety of ongoing pharmacotherapy involves the collection of spontaneous reports on adverse drug reactions (ADRs) associated with the use of medicines.The aim of the study was to analyse approaches to organising a system for collecting information on ADRs associated with the use of medicinal products, taking the Omsk region as a case study.Materials and methods: the authors analysed 200 ADR reporting forms received by the Regional Centre for the Study of Side Effects of Drugs (RCSSED) in 2019.Results: the analysis determined the ways of receiving the forms in the RCSSED. According to the analysis, the ADR reports were submitted by medical organisations in Omsk (86%) and the Omsk region (0.5%), as well as directly by patients (13.5%). The leading sources of reports were clinical pharmacologists (80% of the forms). Most of the reports were on ADRs associated with the use of psychotropic (41%) and antitumour (10%) medicinal products; it is explained by the proactive attitude and high commitment of medical personnel from the specialised clinics in Omsk towards their professional duties. Other important sources of reports in the Omsk region, which contributed to the number of spontaneous reports from patients, were the patient hotline and free consultation appointments with the clinical pharmacologist of the RCSSED on side effects of medicinal products. The article emphasises the leading role of the RCSSED clinical pharmacologist in educating medical personnel—in pharmacovigilance, collecting information about the development of ADRs, and the quality of reporting form filling—and coordinating the activities of the medical and pharmacy services, including the stages of laboratory assessment of medicinal product quality and pharmaceutical consultation of general public.Conclusions: using the example of the Omsk region, the authors demonstrated the structural organisation of the collection of information about adverse reactions associated with the use of medicinal products. An important direction for further improvement of the organisation of ADR monitoring is the interaction with employees of pharmacy organisations, including additional training events for them

Hyporesponse to statin therapy among patients with acute coronary syndrome: prevalence, impact on the development of heart failure in a short-term follow-up

Aim. To study the prevalence of hyporesponse to statin therapy and its impact on the development of heart failure (HF) among patients after acute coronary syndrome (ACS) in a short-term follow-up.Material and methods. This retrospective analysis of outpatient medical records of 400 patients observed at the Omsk Clinical Cardiology Dispensary after ACS was carried out. Optimal medication therapy was prescribed as part of the preferential provision of medicines under the 1H Program, including high-dose atorvastatin therapy (80 mg/day). Low-density lipoprotein cholesterol (LDL-C) was assessed at baseline and 1 and 12 months after therapy. Hyporesponse to statins was defined as the percentage reduction in LDL-C 14; left atrial volume index >34 ml/m2) function.Results. There were 107 patients with hyporesponse (26,8%). Depending on the initial response to therapy, patients were divided into two groups: group 1 (hyporesponse, n=107), group 2 (more pronounced response, n=293). After 1 month, patients in the hyporesponse group had a higher level of LDL-C — 2,4 [2,2; 2,9] mmol/l (Me [25; 75%]) vs 2,0 [1,7; 2,5] mmol/l (p>0,05) in the second group. There was no difference in the prevalence of hospitalizations for recurrent ACS in the compared groups, as well as in the prevalence of new HF cases between groups.Conclusion. The prevalence of hyporesponse to statin therapy was 26,8%, which required correction of lipid-lowering therapy in order to prevent recurrent cardiovascular events. Given the pleiotropic effects of statins that can participate in HF pathogenesis, as well as the inconsistency of current research results, further prospective long-term studies are required

СТАТИНОТЕРАПИЯ ПОСЛЕ ОСТРОГО КОРОНАРНОГО СИНДРОМА: УРОКИ РЕАЛЬНОЙ КЛИНИЧЕСКОЙ ПРАКТИКИ

Aim. To evaluate the effcacy of statin therapy in patients with acute coronary syndrome in real clinical practice and to develop the monitoring of the quality of patients’ management.Methods.  255 patients with acute coronary syndrome who have undergone stenting of the infarct-related coronary artery were included in the study using the continuous sampling method. The follow-up period was 12 months. All the patients received atorvastatin at a dose of 20 mg were included in the «Omsk Segion State Program» (Program) – the control group. The comparison group consisted of 112 patients with acute coronary syndrome who have undergone the stenting of the infarctrelated coronary artery, but who were not included in the Program and were routinely prescribed statins by general practitioners in the outpatient settings. Medical record abstracts and outpatient medical records were analyzed to estimate prescribed statin therapy regimens and clinical and laboratory fndings. The experts analyzed real clinical practice of statin prescription and monitored its effcacy and safety according to the recent guidelines on dyslipidemia. A novel method for improving the quality of statin therapy has been developed and introduced. Statistical analysis was processed using biometric statistical methods.Results. We found that cardiologists (control group) and general practitioners (comparison group) had low adherence to the current guidelines on dyslipidemia. The effcacy and safety of statin therapy regimens and duration were not monitored. Only 9.8% of patients in the control group and 3.6% of the patients in the comparison group achieved the target levels of low-density lipoprotein cholesterol (less than 1.8 mmol/l) within the 12-month follow-up (p = 0.096).Conclusion. Healthcare professionals’ low adherence to the current guidelines on dyslipidemia led to the need to develop the monitoring of the quality of patients’ management within 12 months after acute coronary syndrome.Цель. Провести анализ эффективности статинотерапии больных после острого коронарного синдрома в реальной клинической практике для разработки способа контроля качества ведения пациентов.Материалы и методы. Методом сплошной выборки в исследование включены 255 пациентов, перенесших острый коронарный синдром и стентирование инфаркт-зависимой коронарной артерии, наблюдавшихся у врачей-кардиологов 12 месяцев после события и получавших аторвастатин в дозе от 20 мг в рамках реализации «Государственной программы Омской области "Развитие здравоохранения Омской области"» в части бесплатного лекарственного обеспечения (Программа) – группа контроля. Группу сравнения составили 112 пациентов после острого коронарного синдрома со стентированием инфаркт-зависимой коронарной артерии, не включенных в Программу, получавших статины в рамках назначений врачей-терапевтов в поликлиниках по месту жительства. Проанализированы выписки из историй болезни и медицинские карты амбулаторных больных для оценки данных клинических и лабораторных исследований пациентов, реальной клинической практики статинотерапии. Проведен экспертный анализ реальной клинической практики назначения статинов, контроля их эффективности и безопасности по отношению к актуальным клиническим рекомендациям по дислипидемии. Разработан и внедрен способ улучшения качества терапии статинами. Материал обработан с использованием методов биометрической статистики.Результаты. Выявлена низкая приверженность врачей-кардиологов (группа контроля) и врачей-терапевтов (группа сравнения) к актуальным клиническим рекомендациям по дислипидемии. Не соблюдались объемы и сроки контроля эффективности и безопасности статинотерапии. Отсутствие назначения высоких доз статинов было не обосновано. Это привело к достижению через 12 месяцев наблюдения целевых значений холестерина липопротеидов низкой плотности (менее 1,8 ммоль/л) лишь у 9,8% пациентов в группе контроля и у 3,6% пациентов в группе сравнения (p = 0,096).Заключение. Низкая приверженность врачей к актуальным клиническим рекомендациям по дислипидемии обусловила необходимость разработки способа контроля качества ведения пациентов в течение 12 месяцев после острого коронарного синдрома

Фармакоэкономическое обоснование применения генно-инженерных биологических препаратов в амбулаторных условиях

Objective. Carrying out of the comparative clinical and economic analysis of treatment of patients with rheumatic diseases (RD) by genetically engineered biological agents (GEBA) in conditions of round-the-clock and day-time in-patient departments.Materials and Methods. In a basis pharmacoeconomic calculations on a method "cost minimization" was put the actual quantity of patients (57 persons) with RD who had previously been initiated and carried out GEBA therapy in conditions of round-the-clock in-patient department, and then the patients for eight months were observed and treated GEBA in day-time in-patient department of budgetary establishment of public health services of Omsk region "Clinical Cardiology Clinic".Results. It demonstrated clinical efficiency of application of GEBA in conditions of a day-time in-patient department in the form of statistically significant decrease of the activity of rheumatoid arthritis, psoriatic arthritis on index DAS28 and stable effect on index BASDAI at ankylosing spondylitis with achievement of stable remission of diseases. Adverse events and adverse drug reactions of GEBA were recorded regardless of the conditions of stay of patients that testifies to identity of parameters of safety of carrying out of genetically engineered biological therapy (GEBT) in a day-time in-patient department. The economic effect of application of hospitalization replacement technologies within 8 months at 57 patients amounted to 2 072 934,1 rbl. In recalculation on quantity of patients in Omsk region (120) sum of economy of system of obligatory medical insurance will amount 4 361 142 rbl.Conclusion. The parameter of a difference of costs at treatment by GEBA of patients with RD in conditions of round-the-clock and day-time in-patient departments in system of obligatory medical insurance testifies to necessity of wide introduction for a clinical practice of hospitalization replacement technologies at treatment by GEBA of patients with RD.Целью исследования являлось проведение сравнительного клинико-экономического анализа лечения пациентов с ревматическими заболеваниями (РЗ) генно-инженерными биологическими препаратами (ГИБП) в условиях круглосуточного и дневного стационаров.Материалы и методы. В основу фармакоэкономических расчетов по методу «минимизации затрат» положено фактическое количество пациентов (57 человек) с РЗ, которым ранее была инициирована и проводилась терапия ГИБП в условиях круглосуточного стационара, а затем пациенты в течение восьми месяцев наблюдались и получали лечение ГИБП в дневном стационаре бюджетного учреждения здравоохранения Омской области (БУЗОО) «Клинический кардиологический диспансер» («ККД»).Результаты. Продемонстрирована клиническая эффективность применения ГИБП в условиях дневного стационара в виде статистически значимого снижения активности ревматоидного артрита, псориатического артритов по индексу DAS28 и стабильного эффекта по индексу BASDAI при анкилозирующем спондилите с достижением стойкой ремиссии заболеваний. Нежелательные явления и побочные реакции ГИБП регистрировались независимо от условий пребывания пациентов, что свидетельствует об идентичности показателей безопасности проведения генно-инженерной биологической терапии (ГИБТ) в дневном стационаре. Экономический эффект от применения стационарзамещающей технологии в течение 8 месяцев у 57 пациентов составил 2 072 934,1 руб. В персчете на количество больных в Омском регионе (120) сумма экономии в системе обязательного медицинского страхования составит 4 361 142 руб.Заключение. Показатель разницы затрат при лечении ГИБП пациентов с РЗ в условиях круглосуточного и дневного стационаров в системе обязательного медицинского страхования свидетельствует о необходимости широкого внедрения в клиническую практику стационарзамещающих технологий при лечении ГИБП пациентов с РЗ

Клинические аспекты включения пациентов с ишемической болезнью сердца после реваскуляризации миокарда в программу физической медицинской реабилитации на амбулаторном этапе

Aim. To determine the clinical factors affecting the timely reference of patients with coronary artery disease after myocardial revascularization to Phase 3 cardiac rehabilitation.Methods. 773 patients with coronary artery disease (CAD) who underwent myocardial revascularization were recruited in a study. Of them, 77 (9.96%) underwent coronary artery bypass grafting and 696 (90.04%) underwent PCI. Within 1 month of discharge, patients were examined by a cardiologist in the outpatient hospital and then referred to the cardiac rehabilitation team to assess their eligibility. The eligibility for exercise rehabilitation was assessed based on the results of general examination, clinical and laboratory findings. The prevalence of absolute and relative contraindications to exercise rehabilitation was measured.Results. 10% of CAD patients after myocardial revascularization had absolute contraindications and 29.6% had relative contraindications to exercise rehabilitation. The presence of relative contraindications (exaggerated blood pressure response (>80/100 mm Hg) to exercise or a decrease in systolic blood pressure ≥20 mm Hg, ventricular extrasystole and tachycardia, paroxysmal tachyarrhythmias in response to exercise, active gastroduodenal ulcer, and less than 1 month after its exacerbation, moderate heart valvular disease (aortic stenosis), decompensated carbohydrate metabolism disorders) required the management of risk factors limiting patients on the participation in exercise rehabilitation. The routing of CAD patients after myocardial revascularization at Phase 3 cardiac rehabilitation was developed and introduced in the Clinical Cardiological Dispensary in the Omsk region.Conclusion. Most patients with CAD after myocardial revascularization should be referred to exercise rehabilitation. These patients rarely have absolute contraindications (about 10%). Despite relative contraindications are rather high (about 30%), risk factors limiting patient participation in exercise rehabilitation are managed successfully. Optimal routing of patients contributes to their prompt recruiting to cardiac rehabilitation. Effective management of cardiovascular risk factors allows recruiting more patients in exercise rehabilitation.Цель. Определить клинические факторы, влияющие на своевременность включения пациентов с ишемической болезнью сердца (ИБС) после реваскуляризации миокарда в программу физической реабилитации (ПФР) с использованием тренажеров на третьем (амбулаторном) этапе медицинской реабилитации.Материалы и методы. В исследование методом сплошной выборки включены 773 пациента с ИБС после реваскуляризации миокарда: 77 (9,96%) больных, перенесших аортокоронарное шунтирование, и 696 (90,04%) - стентирование, обратившихся в первые трое суток после выписки из сосудистых центров к врачу-кардиологу БУЗОО «ККД», принятых для диспансерного наблюдения и направленных в течение месяца после перенесенного сердечно-сосудистого события к врачу-кардиологу - специалисту по медицинской реабилитации БУЗОО «ККД». На основании результатов общеклинического и клинико-лабораторного обследований определена распространенность абсолютных и относительных противопоказаний для включения пациентов в ПФР с использованием тренажеров. Оценка динамики эффективности физической реабилитации на тренажерах не являлась задачей настоящего исследования.Результаты. 10% пациентов с ИБС после реваскуляризации миокарда имели абсолютные, 29,6% - относительные противопоказания к участию в ПФР на тренажерах. Наличие относительных противопоказаний (повышение артериального давления в ответ на физическую нагрузку более 180/100 мм рт. ст. или снижение систолического артериального давления ≥20 мм рт. ст., желудочковая экстрасистолия и тахикардия опасных градаций, пароксизмальные тахиаритмии, язвенная болезнь желудка и двенадцатиперстной кишки в стадии обострения и ранее месяца после обострения, умеренно выраженный порок сердца (аортальный стеноз), декомпенсация нарушений углеводного обмена) потребовало коррекции факторов, ограничивших участие пациентов в ПФР. Разработана и внедрена в работу БУЗОО «ККД» маршрутизация пациентов с ИБС после реваскуляризации миокарда на третьем (амбулаторном) этапе медицинской реабилитации.Заключение. Большинство пациентов с ИБС после реваскуляризации миокарда должны быть включены в ПФР на тренажерах, так как абсолютные противопоказания встречаются достаточно редко (около 10%), а факторы, ограничивающие участие в физических тренировках (относительные противопоказания), несмотря на высокую распространенность (около 30%), могут быть скорректированы на этапе кардиореабилитации. Оптимальная маршрутизация пациентов определяет своевременность включения в ПФР. Коррекция факторов риска прогрессирования сердечно-сосудистых заболеваний способствует включению в ПФР наибольшего количества пациентов

Drugs quality management system in Omsk region

The structure of Drugs Quality Control System in Omsk region was characterized. The processes of services life cycle in regional Drugs Center were considered in a framework of active Drugs Quality Management System

Socio-economic and regional aspects of pharmaceutical care to patients with rare diseases in the Omsk region

This article investigates characteristics of the providing pharmaceutical care to patients with rare diseases in Russia, including at the regional level. To improve this system it is useful to study foreign experience in the development, production and registration of orphan drugs

CLINICAL ECONOMY EFFICACY OF TARGETED APPROACH TO ACUTE CORONARY SYNDROME PATIENTS MANAGEMENT WITH PERCUTANEOUS INTERVENTION

Aim. Clinical economical grounding of necessity for continuation of a “State Managed Program of Omsk Region “Development of Healthcare in Omsk Region” (the Program) in allowance granted supply with life saving medications of patients after endovascular treatment of acute coronary syndrome.Material and methods. To the study, by a continuous sampling method, 255 patients included, after endovascular treatment of coronary arteries in acute coronary syndrome during July 1 to December 31 2015, who monthly attended cardiologists office and received free acetylsalicylic acid, clopidogrel and atorvastatin for 12 months. Method of clinical and economical analysis was applied “Increment efficacy of expenses”, and a threshold for self-payment by patients was evaluated.Results. One-year mortality of the Program participants was 1,2% versus 3,5% in non-participants. Hospitalization rate for repeated acute coronary syndrome was 3,5% versus 9% in non-participants; serious adverse event hospitalization rate was less than 1%. All economically active patients were discharged “to work”.Calculated parameter of increment efficacy of expenses with the technology “stenting of coronary arteries and drug supply in 2018 (statin, acetylsalicylic acid, clopidogrel or ticagrelor)” was 215906,93 Rub for every additional survived patient with no hospitalizations for repeated acute coronary syndrome during one year after stenting.Conclusion. Technology of medication supply with life saving drugs of patients underwent endovascular interventions on coronary arteries for acute coronary syndrome is an advantageous investment of budget funds to life quality of patients. The results of the analysis have grounded the necessity to continue program targeted method in acute coronary syndrome patients management after percutaneous intervention taken current clinical guidelines